Deputy Manager
Unichem Laboratories Ltd
Total years of experience :15 years, 11 Months
Leading characterization team of six people for reference standard support to all Unichem locations thought out the India.
Responsible for planning and execution of all reference standard qualification & distribution activity of Impurity, Intermediates & API.
*Fased USFDA Audit in march 2017.
Responsible for all referance standard analytical document pharmacopial compliance for DMF filing to US & European drug market.
API Release & stability batch analysis by XRPD & DSC.
Handling OOS incidence/event Deviation CCP.
phase one investigation.
CAPA recommondation and implement ation.
acts as technical resourse for application maintenance & theory of instrument viz NMR LCMS HPLC prepHPLC XRPD UV IR DSC TGA.
Prepration of SOP STP protocol analytical report.
Procurment of new analytical instrument.
Executing Characterization activity of Impurity, intermediates raw material referance standards.
Responsible for NMR analysis of all API inprocess samples raw material intermediates &impurities by 1H13C DEPT COSY NOE HMBC HSQC VT experiments on JEOL 9.3T NMR spectrometer.
Preparation of charcterization report for all the RM IMP INTERMEDIATE &FINAL API for submission of DMF to EP BP US market.
API stability and release plant batch analysis by DSC & XRPD.
Thermal analysis method developmemt for stability study and polymorphism of APIs.
identification, Isolation & characterization of unknown impurities generated in API Rout of synthesis at plant by Reverse pahse hplc and mass spectroscopy.
Determination of m/z for unknown impurities observed in finish product.
LCMS method development and analysis of inprocess, intermediate and final drug samples.
answering ANDA DMF Quries related to characterization.
carryover study impurities in API for DMF FIlling by ION Chromatography.
Qualification of Referance standard by HPLC PURITY, Identification by spectroscopic techniques.
• Analyzing the samples by DNMR, 1H, 19F, CMR, DEPT, NOESY, and COSY using almost all deuterated solvents.
• Structural conclusions are reached by analysis and spectral interpretation of data resulting from NMR, MASS, IR, UV, DSC, XRD & elemental analysis techniques for WS, RS, INT& IMP.
• Resolving DMF Queries regarding identification test & characterization.
• Doing comparative study of Reference listed drugs with In-house products.
• Doing thermal analysis of the samples by technique viz.DSC, TGA.
• Responsible calibration of probe as per SOP.
• Preparing characterization of standards viz. impurity, working, reference.
• Performing 2D experiments like HMBC, HSQC.
• HPLC - Reaction monitoring & Impurity analysis.
• LCMS-Direct mass analysis of newly designed reaction, intermediates & final.
• LC/MS of all library compounds with purity specifications.
• Analyzing the samples by 1H, 19F, CMR, DEPT, NOESY, COSY and 2D experiments for significant samples using all deuterated solvent.
• Carried out DNMR, QNMR/Purity of Compound by internal standard method.
• Cryogen filling. (Liquid Nitrogen, Liquid Helium refilling) & Routine maintenance.
Second Rank In University
Yashwantarao chavan college of science karad dist satara